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Fundamentals of Risk Management &
Patient Safety for Community Health
Centers
On-site RM Training Seminar – November 2008
Petra S. Berger PhD RN, CPHRM
Healthcare Risk, Quality, and Patient Safety Consultant
[email protected]
-
Phone: 517–281-7816
1
Learning Objectives

Demonstrate understanding of risk issues inherent
in providing community health center services

Explain leadership tools & methods related to:


Proactively identifying risk concerns, and

Responding from the risk control, quality, and
patient safety perspective
Recognize the critical role played by patients and
families regarding high risk aspects of patient care
2
Definitions
Risk Management & Liability Coverage

What is “Risk management” @ CHCs

Dir. & Officers: Financial, Contracting
Employment Practice, Workers’ Comp
General Liability: Property etc.


Concepts in Professional Liability



Risk identification & reporting
Clinical Liability review
Risk intervention: immediate & QI referral
3
VITAL BRIDGE OVER TROUBLED WATERS
QUALITY MANAGEMENT
Patient Safety = Q. I.
Risk Management
= identify risk – respond – prevent
4
CORE PURPOSE of RISK MANAGEMENT
S T O P ADVERSE OUTCOMES

Preventing Patient harm

Protecting Healthcare facility from



litigation and financial loss
patient and community distrust
Protecting involved Providers
5
QUALITY OUTCOMES & RISK ASPECTS
on O N E Quality Management Platform

Patient Satisfaction


Clinical Effectiveness


after hours coverage
Regulatory compliance


missed diagnosis
Policies & Protocols


complaint management
informed consent
Efficiency, UR, Cost control
6
Risk & Quality Leadership Roles

A culture of safety in which individuals can
draw attention to potential or real hazards,
barriers, gaps, or failures without fear

Non – punitive reporting

Strategic Risk & Quality planning based on
Prioritization
Implementation of practice guidelines and
procedures through Monitoring and Q. I.


“Knowledge transfer” of patient safety practices
7
Health Center Trends and Issues
FTCA CLAIMS DATA





Claims Occurrence
Error in Diagnosis
30%
Treatment related
21%
Medication related
10%
OB Related
22%
Surgical Procedures 6%
Claims Location
Health Center 65%
Hospital 35%
8
Liability Question: Allegation of NEGLIGENCE
Duty – based on existing provider-patient relationship
To exercise degree of care that a reasonable
& competent provider would exercise under
same or similar circumstances
Breach of Duty
Plaintiff must show that defendants failed to
exercise ‘reasonable’ care, and adherence to
established clinical standard (expert testimony)
Injury proximately CAUSED by breach (foreseeable)
9
Case: Incomplete Medication History

58-year-old male patient was scheduled for a
major diagnostic procedure at the hospital
where a certified registered nurse anesthetist
(CRNA) provided conscious sedation.

A required copy of the clinic medical record
was sent preoperatively.
No mention was made of the patient’s seizure
medication.

10
Case: Seizure & Respiratory arrest




No recent blood level had been obtained related
to the patient’s seizure medication.
Patient compliance with the medication was
unknown.
The patient underwent scheduled procedure
Patient experienced a grand mal seizure during
the procedure and had a respiratory arrest.
Intubation was delayed and the patient suffered
permanent brain damage.
11
Immediate RISK INTERVENTION

PATIENT STATUS?

Medical Record As Core Evidence


Privileged & protected information
Fact-based investigation



No premature conclusions
Timelines and event analysis (RCA)
Sequestering evidence
12
Alleged Negligence: Duty? Breach?
A. Clinical standards of care = ‘duty’

Monitoring, patient medication & document

Test result reported & signed off by provider

Treatment plan updated, w/ or w/out change

Reliable medical record system @ hand off
with external medical providers and hospital
B. [CRNA & hospital standards of care]
13
P o l i c y & P r o c e d u r e s:
Standards by which Care is judged

Difficult to defend policy & procedure:

If not based on evidence-based guidelines

If no allowance is made for clinical
judgment to vary from protocol

If local practice not the same as policies

If not monitored for adherence
14
RISK IDENTIFICATION

Generic screens: waiting times, no show rate

Incident (or occurrence) reporting (1 - 30%)
 Omitted or delayed diagnostic reporting
 Adverse medication event –outcome /process
 Patient or family complaint; Feedback


Staff feedback & surveys

Risk reporting marathons
Electronic information system
15
Procedures of
Incident reporting

H o w to complete incident report

Fact based, objective, w/ timeline
 No speculation, opinion, blaming

not: “gave wrong med”

Persons notified: RM, provider, family

No copy – no staples – no mention, MR placement

Medical record documentation

Date & time, provider actions

Patient’s clinical status; quotes not adjectives
NO PERSONAL NOTE KEEPING

16
Risk vs. Quality measures: need both
Sample RISK MEASURES





Patient complaints
Misfiled and non initialed test results
Missed diagnosis: Cancer
Insulin medication error and patient harm
Adherence to Anticoagulation guidelines
Sample QUALITY MEASURES



Medical record documentation audits /criteria
Diabetic HgbA1C baseline & improvement
Pediatric Immunization rates
17
TJC: National Pt Safety Goals

Patient identification

Verbal orders
Hand off @ transition
Medication reconciliation
Critical lab value reporting
Patient involvement in care
Suicide assessment





18
Risk aspect #1:
Risk aspect #2:
Patient communication
Provider Team Communication

PATIENT COMMUNICATION

Patient interview & Treatment planning

Health instruction – literacy – interpreters
Patient feedback & complaints


PROVIDER TEAM COMMUNICATION
 Hand off @ transition points
 Inter-provider relations & teamwork
19
Risk aspects #3: The Medical Record
Risk aspects #4:
Clinic Operation & Flow
The Medical Record

Chart content & What To Document

Legal aspects: alterations, legibility, etc.

Confidentiality & Release of information
Clinic Operation & Flow



Continuum of care (62% claims) vs. fragmentation
Diagnostic test tracking
After hours coverage; telephone triage
20
Risk aspects #5:
Risk aspects # 6:




Clinical Practice
Medical Mis-Diagnosis
Patient assessment & monitoring
Treatment & Use of Practice Guidelines
Medication prescription practice
Complications, preventable

OB, Surgical procedures, Emergency visit
Most frequent Mis-Diagnosis




Inadequate medical history & physical exam
Insufficient diagnostic work-up
Incorrect interpretation of diagnostic tests
Incomplete follow-up
21
Risk aspect # 7:
Medication Safety
Risk aspect # 8: EQUIPMENT – EOC – EMERGENCY
Adverse Medication events related to phases:








Product labeling, packaging, nomenclature
Prescribing: Indications, interaction, off label
Dispensing: compounding, distribution error
Administration: wrong drug/ dose/ route
Emergency Preparedness
Crash cart (incl. pediatrics) & checks
Behavioral
Building /weather
22
Risk aspect #9:
Risk aspect #10:
Clinic Staff performance
Medical Provider Quality

Staff qualification & orientation
 Clear directives & protocols
 Orientation and Training
 Staffing levels
 Material resources


Medical Provider Quality & Peer review
Review mechanism – why, who and how

Data sources and Measures


Quality indicators
Risk indicators and events
23
Risk Aspects of Clinic Services I
24
High Risk Clinic Service Aspects – I








Diagnostic ordering and test tracking
Patient & Family Communication
Informed consent and refusal
Telephone triage, After hours, No shows
Patient satisfaction & complaints
Health Literacy
Non compliance
Termination of Care
25
Risk aspect #4:
Diagnostic test tracking & QC audits

Test ordered by med. provider & log

Request form created - copy retained

Test completed - patient compliance?

Results received & logged in / ck log

Results reported to provider (same
day for abnormal /critical results)

Patient notification documented
26
Risk aspect #1: Patient communication

Patient assessment & interview

Treatment planning & consent



Health instruction – literacy – interpreters


Conflict resolution; Non compliance
Termination of care
Explain back / read back
Patient feedback & satisfaction

Complaint management
27
Medication compliance
PATIENT COMMUNICATION

Medical literacy & English proficiency


Lay language
Validated understanding

Hearing, vision limitations ?

50% non-adherence to prescribed meds

8.4 mio not taking hypertension meds
28
Why Do People Sue?

Study of law suits against a large medical
center indicated Problematic Relationships:

Perceived desertion of the patient

Devaluing patient and/or family views

Poorly delivering health information

Failing to understand the perspective of
patient and/or family
29
Informed Consent


Used whenever an invasive procedure is
proposed that carries a material risk of harm
Need to have a discussion of the





Procedure and benefits (P)
Risks of the procedure ( R)
Alternatives to the procedure (A)
Questions asked (Q)
What should be documented?

Consent process, any questions answered
30
Informed Refusal - signed

Should be obtained whenever refusal to
have a test or procedure done may have
adverse results – related to index of suspicion

Examples

Mammograms

Chest or other x-rays

Cardiac work-ups

Lumbar punctures
31
Telephone triage & Legible Documentation
Using protocols adopted by medical staff,
or direct consultation w/ med. provider

Name of Caller & purpose of call
Advice & orders given (prescription refills)
Follow-up instructions
Date, time, AND initial of provider

Review through Q.I. process




Based on criteria of clinical protocols
32
Telephone communication

Document phone calls incl. AFTER HOURS
calls, in the medical record if the following
was discussed:
 medical symptoms, new or continued
 abnormal test results reported
 medical advice offered
 questions about medical treatment
 prescriptions provided
33
Missed appointments – No Shows

Tracking high-risk patients who miss
scheduled appointment
 Pending diagnostic results?

Documenting all notification attempts

Include medical implication of missing
appointments

If worsened outcome possible, a certified
letter is sent, with copy & receipt in medical
record
34
Risk ID through Patient Complaint

Categorize types of complaints

Prioritize by severity & risk level

Establish who is responsible for
responding to the complaints

Log and trend complaints & resolution

Address systems issues through P.I.
35
Risk-related Inventory
Reasons for Care Termination

Group A


1. Repeatedly missing appointments w/out prior notification
2. Disagreement over treatment recommendations
3. Non-adherence /non-cooperation w/ treatment plan

Group B


1. Verbally disruptive and hostile behavior toward medical
provider and/or staff [by patient or family /caregiver]
2. Threatening behavior toward medical provider / staff

Group C

1. Noncompliance with office policy re: prescriptions

Group D

1. Delinquency on bill payments

36
Termination of Care
Solution of ‘last resort’

Patient given notice of termination


Patient given reasonable amount of time in
which to obtain alternative care


Evidence of certified letter in chart
Usually thirty days
Patient given assistance in obtaining
alternative care

e.g., a list of appropriate potential providers
37
Perhaps not now -- Termination of Care


During treatment for an imminent or unstable
medical condition

Mental health disability if yet untreated

in process of medical workup for diagnosis
Pregnant patient, approx. last trimester

Pregnant patient approx. last 2 trimesters if high risk

Patient in immediate postoperative stage

Precaution w/discrimination issues, e.g. HIV

Remote area and lack of alternate providers
38
Risk Aspects of Clinic Services II
39
High Risk Clinic Service Aspects – II

Staff communication & Human Factors

Credentialing, Privileging, Peer review

Clinical risk factors in Perinatal, Surgical,
Behavioral Health, and Dental Services

Emergency Response
40
Provider Team Communication

Half of communication breakdowns
occurred as patients were HANDED OFF
@ TRANSITION POINTS between
providers (verbal & written)

2/3 of serious medical errors occur @
transition points (TJC reports)

Inter-provider relations & teamwork
41
Risk aspect #9: STAFF PERFORMANCE

Staff qualification & orientation

Clear directives/protocols & Training

Staffing levels & Material resources

Human factor remedies:
distraction, memory overload, fatigue,
confirmation bias

Provide Performance feedback
42
Human Factor:
Patient safety Ownership & Just Culture

Imperfect behaviors, lapses, oversight


At-risk behaviors -- e.g. shortcuts


Inadequate realization of risk, poor risk awareness,
inadequate diligence – systems barriers & gaps?
Intentional conduct that unintentionally increases
risk of harm: policy non compliance re: double checks
Reckless behavior /questionable moral judgment

Recognition of high risk, BUT risk is disregarded;
commission of intentionally hazardous acts -- cause
violation of trust; e.g. alteration of medical records
43
Quality & Peer review:
Clinical Practice Pattern

Medical evaluation & Treatment





Medication therapy
Pre-natal risk factors
Pre-, intra- & post-surgical Tx & evaluation
Use of Practice Guidelines: decrease variability


Complex medical condition: Cancer, Co-morbidities
Asthma, Anticoagulants, Stroke, Pediatric Fever
Complications, preventable

OB, Surgical procedures, Emergency
Sample protocols can be accessed at http://www.guideline.gov/
44
Clinical Protocols w/ Risk Focus







Pre natal risk assessment & OB practice
Fever in Children (ACEP)
Stroke
Chest pain
Abdominal pain
Anticoagulant Management
Sample protocols can be accessed at
http://www.guideline.gov/
45
Pain assessment: a diagnostic Key

Assessment (Pain & Headache) & DOCUMENT
 Location and Radiation (All locations)
 Onset – Duration - Frequency
 Severity (per scale 1 – 10)
 Pain Quality or Type (pressure, cramps etc.)
 Last dose of Pain medication / frequency
 Recent Health history, events, procedures
 Other S & S: weakness, numbness, neck pain,
stiffness, photophobia, diaphoresis, N-V, SOB
(LMP)
46
Confirmation Bias
Paris in the
the Spring
Once we decide that we “know” what
something is, we tend to exclude or neglect
information that may be contrary to our
original perceptions
47
Pre-natal risk assessment

PRE NATAL ASSESSMENT per protocol (standardized)


Consistent documentation, prenatal visits
Prompt high risk referral

PRE NATAL MED. RECORD TO HOSPITAL @ 36 wks

Maternal conditions: hypertension – prior
PE – diabetes – drug & alcohol – antepartum
hemorrhage – cardiac risk factors
http://www.rmf.harvard.edu/; AAFP standards / ACOG standards
48
SURGICAL PROCEDURES

Scope of Privileges

Patient assessment, pre procedure



Informed Consent and Refusal


History & Physical
Prev. complications related to procedures
Patient education / Health literacy
Post procedure follow up:

Complication? Infection? Pain?
49
BEHAVIORAL HEALTHCARE

Initial Assessment & Treatment Plan



Suicide assessment and Safety precautions
Case management
Medication therapy (?informed consent)


Monitoring of effects and compliance
Patient /family education: purpose /side effects

On-going acuity assessment & referrals

Documentation standards & confidentiality
50
Suicide assessment - Document


Concurrent Dx: depression \bi-polar \psychosis
Family history


Previous patient attempts
Lack of social support

Recent significant loss

Alcohol /drug intoxication
Terminal or chronic debilitating disease
Abrupt withdrawal from normal routine

John Hopkins Health Information, 1998. Spotting the Warning Signs of Suicide


51
Incidental Assessment
of Abuse or Neglect

Domestic violence: child – dep. adult – partner
Mandatory reporting laws: suspect, not prove

How to assess:


Ask about abuse in private w/ respect, non blame
Feel safe? What stress? Should I be concerned?

Emergency plans? Resources: friends, family?

Contusions, abrasions (head, chest, abd); fractures
Abuse during pregnancy



DOCUMENT in detail a n d objectively
52
Human Performance Factor
for Medical Providers

Clinical /technical judgment & knowledge

Diagnostic practice pattern & experience

Medication knowledge – indications,
interaction, off label use, etc.

Understanding Patient needs: dialogue,
health education & clinical monitoring
Communication skills: providers, patients
Documentation skills


53
Credentialing Focus
Initial credentialing varies from re- credentialing

INITIAL:
Licensure verification, References re: privileges
Qualifying education & experience, NPDB

RE-CREDENTIALING:
Quality & Risk data required



Which value-added measures to select
How to obtain the data efficiently
What to do with quality information
54
Credentialing process:
Initial

Responsibility of medical staff and board

Include all mid level providers & residents

Documented process to grant privileges


Reference letters address privileges sought

Qualifying education & experience - criteria
NPDB query, all states w/ previous practice


Initial criminal background check
Check all staff & volunteers, pertinent states
55
Re-credentialing & Quality indicators

Patient assessment & monitoring (MR)

Diagnostic services and follow up

Unclear /inconsistent documentation

Medication prescription pattern

Guideline adherence: e.g. Anticoagulant Tx

Communication – team & patient relations
56
California Dept. Managed Health Care (DMHC) Fines
Kaiser Health Plan for Lack of Quality Oversight (7/07)
DMHC observed that of 228 peer-review files, onethird were deficient, such as
 Not handling quality concerns promptly
 Not fully considering a physician’s
complaint history in evaluating peerreview matters.
 Not carrying out corrective actions
HRC Alerts at http://www.ecri.org
57
Credentialing Files: Risk & Quality section

Credentialing files organized into 2 sections

Separate Quality file per practitioner

Sect. A:
Guideline adherence; Documentation

Sect. B:
P.C.E. = Potentially compensable event
Adverse event review
Peer review result

Top Confidential, keep secured
58
Risk aspect #8:
EQUIPMENT – EOC – EMERGENCY RESPONSE
Emergency protocols implemented and monitored

Medical emergency

1 BLS trained staff on-site at all times

Crash cart (incl. pediatrics) & checks

Behavioral

Building /weather (power outage; fire)
59
Pediatric office emergencies



“…occur more commonly than perceived by
family physicians; most offices not well
prepared
Obtaining training in pediatric emergencies,
performing mock ‘codes’ to assure office
readiness can improve actual handling of
pediatric emergencies
Common airway emergencies include foreignbody aspiration and croup.”
Source: Wheeler, Kiefer and Poss. American Family Physician, Pediatric Emergency
Preparedness in the Office, June 1, 2000.
60
EQUIPMENT LIABILITY
How to protect against risk




THE EQUIPMENT WAS:
used in reasonable manner (vs. ‘user error’)
inspected for obvious defects prior to use
on regular preventative maintenance schedule
All staff using the equipment were trained
Procedures developed & staff trained on
how to respond in case of equipment failure
61
Environment of Care
Infection control & Hazardous Material

Develop, implement and monitor an Infection
control (I.C.) plan pertinent to the facility

Involve I.C. professional

Trend I.C. issues & take corrective action

Protect staff, providers, patients, and
visitors from hazardous material
62
Behavioral Emergencies

OSHA cites healthcare facilities under general
duty clause for failure to prevent patient violence
against healthcare workers

Medical providers & staff exposed to potentially
dangerous confrontations incl. ill-intended
trespassers

Security audits needed to reveal problems
Address aspects of potential risk of violence

Source: ECRI, HRC Risk Analysis – Overview: Managing Risks in Physician Practices, July
2003.
63
Risk Aspects, Clinic Services III
64
High Risk Clinic Service Aspects – III

Medical Record Documentation

Medication Management
65
Risk aspects #3:
The Medical Record - Content

Medical history, comprehensive & in ink



Lab work, other diagnostic results



Diagnosis & Current medical problem list
Double check @ each visit before chart returned
All results initialed by medical provider: QC
Patient notification documented: QC
Current medication log in ink (herbals, OTC)


Double check @ each visit before chart returned
Cross off old info w/single line, explain i. e. D/C
66
Personal Health Record (PHR)

Manual or electronic version


Portable / Paper / web based / CD ROM
Content







Updated medication list incl. OTC
Allergies & immunizations w/ dates
Significant recent diagnostic test results
Medical history incl. procedures
Special diet and other health measures
Health insurance information
Living will
67
What To Document – Concurrent

Referrals & consultations

Patient notification

Instruction to patient /family, in writing

Questions addressed
Patient's failure to keep appointments

Informed consent / refusal DISCUSSION

All entries timed, dated & signed /initialed

68
Guess that Prescription
 Handwritten prescriptions are often misread
 In the prescription above, the drug name
“Avandia”
 was incorrectly interpreted as Coumadin.


http://www.medscape.com/viewarticle/557740?src=mp
From American Journal of Health-System Pharmacy
69
Risk & litigation aspects
MEDICAL RECORD DOCUMENTATION

?Treatment rationale; ?Diagnostic Follow Up

Omissions \ delays

Contradictions; confusion between provider

Finger pointing, subjective statements

Corrections: Write overs & White out

Illegibility & error prone abbreviations

Altered Medical Records; “Late entries”

Do not: mention ‘incident report completed’
70
Alteration of Medical Records




A recent case in Ohio involved a physician who
“whited out” the following phrase:
“I do not feel that a biopsy is necessary
at this time”
And replaced it with:
“The patient does not want a biopsy at
this time”
Jury returned a verdict for $3 Million in an
otherwise defensible case !
Destruction of records is equally detrimental
71
Policy development
Confidentiality & Release of information
Release of information





verify request authenticity
Incapacitated adults; Minors
Families of deceased patients
Law enforcement officials /agencies
Employers and other third parties
Protecting Confidentiality




Leaving message on answering machine /at work
Sign in sheet at front desk & privacy
Privacy re: staff conversation /phone calls, reception area
Faxing protocols
72
Faxing documents & Confidentiality

What not to fax: HIV results, mental health records

Avoid sending to general locations, e.g. mailrooms

Request that the recipient acknowledge receipt

Include confidentiality statement on fax cover sheet

If intended recipient does not receive fax because
of incorrect dialing, fax request using incorrect fax
number & request return or destruction of material
73
Medication Safety
Adverse Medication events related to phases:

Product labeling, packaging, nomenclature

Prescribing: Indications, interaction, off label

Antibiotics, anticoagulants, narcotics,
cardiovascular, steroids; serum levels

Dispensing: compounding, distribution error

Administration: wrong drug/ dose/ route
Source: National Coordinating Council on Medication Error Reporting and
Prevention –www.nccmerp.org
74
PROVIDER COMMUNICATION
& MEDS
PHARMACIST function

Legible prescriptions for Pharmacist

Including indications / purpose and/or
diagnosis

Include all of the following components in order:
dose – strength – units/metric – route – frequency

Guarding against LASA drugs:
 Restoril ordered, Remoran dispensed
(Antidepressant)
 Patient also taking another anti-depressant
75
PROVIDER COMMUNICATION & MEDS
NURSES and Verbal Orders

Restricting Verbal Orders – Limit to Emergencies

Speaking slowly & deliberately

Specific indications /purpose provided for all
medication, including for “as needed” P.R.N.

“Read back” verification, with spelling of drug
name as necessary


Caution w/ sound alike and high alert drugs
Nurses to ask for clarification of illegible or
unclear orders; eliminating second guessing
76
Clinical Protocols
Documenting MEDICATION MONITORING

Cholesterol – liver panel, lipids

Anticonvulsants – drug levels, liver, CBC

Chronic anti-inflammatory /arthritis meds


kidney function, esp. geriatric patients
Anticoagulant

Warfarin / Coumadin – INR, PT, PTT
77
Anti Coagulant Monitoring
heparin – warfarin – other anticoagulants

Warfarin dispensed by pharmacy per Patient

Clinical pharmacist resource support

Education about anticoagulants for
prescribers, nurses and pharmacists

Patient /caregiver education includes



reasons and benefits of therapy
follow-up monitoring /compliance
dietary restriction; potential drug interaction
78
ABBREVIATIONS “Do Not Use” list

- NOT: U (unit) or IU (international unit)
- NOT: Q.D., Q.O.D.
- NOT: MS, MSO4, MgSO4
- NOT: Trailing zero (X.0 mg)- write X mg

- DO use leading zero (NOT .X mg) instead




Do write 0.X mg
79
Sample drugs & Medication security

Manage controlled substances

Manage sample drugs




Storing & securing (authorized access;
log in & out)
No prescription pads in exam rooms
Monitoring expiration dates
Dispensing function


log in & out; lot #
Recall function
80
Protocol: Prescription refills

Medical records reviewed prior to renewals for


Needed labs,
Most recent & next appointment (missed appt?)

Medication renewals limited to patients
previously seen by medical provider in clinic

Pain med renewal ONLY by Medical provider

Document:
 Medication name, dose, amount, date of last
appointment, completed labs as applicable
81
Medication Reconciliation

RN/ MA intake interview: takes time
 Interview skills
 Medication knowledge
 Pt. brings in all current medications & OTC
 Establish / update Medication Inventory




Keep in visible location on pt. chart
Patient keeps copy and updates
Patient uses Medication inventory daily
Update medication supply @ each visit to
reduce refill requests between visits
82
• Select problem
process
• Make change
permanent
(standardize) or
• Understand
the process
• Continue the
PDCA cycle
• Decide on
process steps
to improve
• Collect data
• Analyze data
• Data collection
• Determine the
effectiveness
of the change
• Implement the
change /pilot
• Data analysis
83